Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0487-0111 A · 3 trials · 2 indications
Number of events
Measured as hours picograms per milliliter (h\*pg/mL).
Measured as hours picograms per milliliter (h\*pg/mL).
Number of events
| Arm | Type | Description |
|---|---|---|
| Cohort A1 | EXPERIMENTAL | Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo. |
| Cohort A2 | EXPERIMENTAL | Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo. |
| Cohort A3 | EXPERIMENTAL | Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo. |
| NNC0487-0111 | EXPERIMENTAL | Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4. |
| Part A: Single ascending dose (SAD) | EXPERIMENTAL | Participants will receive a single dose of any of the six different dose levels (1, 3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part B: Multiple ascending dose (MAD) | EXPERIMENTAL | Participants will receive NNC0487-0111 once daily for 10 days at any of the five different dose levels (3, 6, 12, 25 and 50 milligrams (mg)) of NNC0487-0111 A or matching placebo in a sequential manner with the dose increasing between cohorts. |
| Part C | EXPERIMENTAL | Participants will receive NNC0487-0111 A or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12. |
| Part D | EXPERIMENTAL | Participants will receive NNC0487-0111 B or matching placebo once-daily for 12 weeks: 3 or 6 mg for weeks 1-2, 6 or 12 mg for weeks 3-4, 12 or 25 mg for weeks 5-6, 25 or 50 mg for weeks 7-8, 25 or 50 mg for weeks 9-10 and 50 or 2\*50 mg for weeks 11-12. |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 A | DRUG | Participants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy. |
| Placebo A | DRUG | Participants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy. |
| NNC0487-0111 C | DRUG | NNC0487-0111 C will be taken orally. |
| Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) | DRUG | Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally. |
| Acetaminophen - 500 mg/15 ml | DRUG | Acetaminophen - 500 mg/15 ml will be taken orally. |
| NNC0487-0111 B | DRUG | Participants will receive NNC0487-0111 B tablet once daily. |
| Placebo B (NNC0487-0111 B) | OTHER | Participants will receive placebo matched to NNC0487-0111 B tablet once daily. |
| Placebo A (NNC0487-0111 A) | OTHER | Participants will receive placebo matched to NNC0487-0111 A tablet once daily. |
Inclusion Criteria: 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male Chinese participants, age 18-55 years (both inclusive) at...
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NNC0487-0111 A is an investigational small molecule being developed by Novo Nordisk A/S (NVO) for the treatment of obesity and overweight. It is currently in Phase 1 clinical development, with completed trials studying its effects in people with these conditions.
NNC0487-0111 A is a small molecule being studied for its effects on weight management in people with obesity or overweight. The specific molecular target has not been disclosed, so the exact mechanism of action is not publicly detailed.
NNC0487-0111 A is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in obesity and overweight.
NNC0487-0111 A is in Phase 1 clinical development. All three of its clinical trials have been completed, with a total enrollment of 187 participants across studies in the United States, Canada, and China.
NNC0487-0111 A has completed three Phase 1 trials: NCT05369390 in the US (144 participants), NCT06461039 in Canada (43 female participants), and NCT07121153 in China (36 male participants). All trials focused on obesity or overweight, with the latter two also examining drug interactions and effects in specific populations.
NNC0487-0111 A is the drug name used in clinical trial records, and it is also referred to simply as NNC0487-0111 in some study titles. Both names refer to the same investigational compound being developed by Novo Nordisk.